Associate Director, Clinical Quality Assurance

Company : Rhythm Pharmaceuticals

Country: United States

Location : Boston, Massachusetts

Post: Tue, 30 May 2023 08:39:30 GMT

Expires: Tue, 27 Jun 2023 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Company Overview

Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the care of people living with rare melanocortin-4 receptor (MC4R) pathway diseases. Working at Rhythm means that you are part of a team that’s passionate about transforming the lives of people living with hyperphagia (pathological, insatiable hunger) and severe obesity caused by rare MC4R pathway diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.

 

Opportunity Overview

Independently manage domestic and international audits of sites, documents, databases, vendors, and internal systems in compliance with GCP and Rhythm policies and procedures; assess impact of audit findings on subject safety, data integrity, and business operations.

Develop the risk-based audit and compliance strategy for clinical programs; assist program teams in implementing corrective and preventive actions; and enable teams to be inspection ready.

Provide expertise in Good Clinical Practice (GCP), Good Laboratory Practice (GLP); Good Pharmacovigilance Practice (GPvP); US Food and Drug Administration (FDA), International Council for Harmonization (ICH), and European Medicines Agency (EMA) regulations and guidelines; and industry standards.

Lead Clinical Quality Assurance (CQA) activities for assigned clinical programs and proactively identify compliance issues/risks and recommend mitigations.

Lead investigations into significant quality issues, scientific misconduct, and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities.

Lead GCP health authority inspections; lead clinical teams in preparation for announced inspections and provide GCP compliance technical support during inspections of investigator sites and Rhythm. Facilitate appropriate and timely inspection responses and follow-up actions.

Assist with preparations for inspection-readiness activities for Rhythm, contract research organizations (CROs), and investigator sites.

Provide oversight of GCP vendors through audit and governance programs.

Provide ad hoc quality support to Rhythm’s preclinical programs.

Review key safety, clinical, and regulatory documents such as protocols, Clinical Study Reports (CSRs), Development Safety Update Reports (DSURs), Investigator Brochures (IBs), Investigational New Drug (INDs) applications, and New Drug Applications (NDAs).

Collaborate cross-functionally and with external parties to promote a high level of quality and consistency across clinical programs and to identify and mitigate GCP quality and compliance issues.

Escalate systemic and/or critical problems and recommend appropriate solutions for immediate and long-term resolution.

Train and mentor employees on global GCP regulations and guidance as needed.

 

Qualifications and Skills

Bachelor’s Degree in a clinical/scientific field, is preferred, with 8+ years of relevant industry experience.

6+ years of GCP-related Quality Assurance or relevant clinical trial experience.

Experience supporting Regulatory Authority GCP Inspections.

Extensive knowledge and/or awareness of ICH GCP, and applicable global regulations and guidance for clinical development. Knowledge in cGMP regulations is a plus.

Excellent communication, writing, and presentation skills for effectively interfacing with internal and external stakeholders.

Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines.

Demonstrated ability to work independently and in a team environment.

Ability to assess complex issues, propose viable solutions, and follow through to resolution.

Demonstrated ability to organize cross-functional teams and execute on aligned tactics.

Ability to foster effective relationships with vendors, investigators, and colleagues.

Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required.

Requires approximately 25% travel.

 

This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.

 

More about Rhythm

Rhythm is a global, commercial-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of hyperphagia and severe obesity due to rare melanocortin-4 receptor (MC4R) pathway diseases. This is a key biological pathway that regulates weight and hunger. A central element of Rhythm’s mission is to improve the understanding of these diseases and develop management strategies for patients who have no treatment options available to them. Rhythm was founded in 2008 and is based in Boston, MA. The company’s clinical development program is currently focused on several rare MC4R pathway diseases. For healthcare professionals, visit (url removed) for more information. For those who may be affected or would like to learn more, visit (url removed) for more information.

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